Biological Sex and CTEPH-related RV Dysfunction and Recovery (BIOSPHeRe)

Study Purpose

1. To identify biological sex differences in baseline RV function in CTEPH. 2. To identify biological sex differences in recovery of RV function after PTE surgery in CTEPH. 3. To determine if sex hormone levels relate to RV function at CTEPH diagnosis and during recovery after PTE.

Recruitment Criteria

Accepts Healthy Volunteers

Healthy volunteers are participants who do not have a disease or condition, or related conditions or symptoms

Study Type

An interventional clinical study is where participants are assigned to receive one or more interventions (or no intervention) so that researchers can evaluate the effects of the interventions on biomedical or health-related outcomes.

An observational clinical study is where participants identified as belonging to study groups are assessed for biomedical or health outcomes.

Searching Both is inclusive of interventional and observational studies.

Observational [Patient Registry]
Eligible Ages 18 Years and Over
Gender All
More Inclusion & Exclusion Criteria

Inclusion criteria.

  • - Adult (≥18 years old) patients diagnosed with CTEPH per current guideline standard42.
  • - Subject must have a baseline TTE (within 3 months of diagnosis) with adequate images for RVGLS analysis.
  • - Subject must have a right heart catheterization (RHC) at the time of diagnosis.
  • - To be included in the Aim 2 analysis, patients must undergo PTE surgery and have a TTE performed 3-9 months after surgery with adequate images for RVGLS strain analysis.
Exclusion criteria.
  • - Unclear or mixed PH diagnosis as designated by an expert clinician at Intermountain PH center.
  • - Any subjects <18 years of age.
  • - Patients diagnosed during pregnancy.
- Patients without a TTE and RHC at time of diagnosis

Trial Details

Trial ID:

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Phase 1: Studies that emphasize safety and how the drug is metabolized and excreted in humans.

Phase 2: Studies that gather preliminary data on effectiveness (whether the drug works in people who have a certain disease or condition) and additional safety data.

Phase 3: Studies that gather more information about safety and effectiveness by studying different populations and different dosages and by using the drug in combination with other drugs.

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Lead Sponsor

The sponsor is the organization or person who oversees the clinical study and is responsible for analyzing the study data.

Intermountain Health Care, Inc.
Principal Investigator

The person who is responsible for the scientific and technical direction of the entire clinical study.

Principal Investigator Affiliation N/A
Agency Class

Category of organization(s) involved as sponsor (and collaborator) supporting the trial.

Overall Status Recruiting
Countries United States

The disease, disorder, syndrome, illness, or injury that is being studied.

Additional Details

Aims 1 and 2 together comprise a retrospective cohort study. We will identify historical subjects with newly diagnosed CTEPH using a clinical database. We will perform TTE strain analysis (RVGLS) to compare RV function between the biologic sexes at diagnosis and after surgical correction of CTEPH (to assess recovery).

Arms & Interventions


: Retrospective Cohort Aim 1

Aims 1 and 2 are retrospective and will be conducted with the same dataset, just at two different time points (at diagnosis of CTEPH and after PTE surgery). For simplicity, aims 1 and 2 will be combined into one section throughout the protocol.

: Retrospective Cohort Aim 2

Aims 1 and 2 are retrospective and will be conducted with the same dataset, just at two different time points (at diagnosis of CTEPH and after PTE surgery). For simplicity, aims 1 and 2 will be combined into one section throughout the protocol.

: Prospective Cohort Aim 3

Aim 3 is prospective and will enroll a distinct set of patients from Aim 1 and 2.


Contact a Trial Team

If you are interested in learning more about this trial, find the trial site nearest to your location and contact the site coordinator via email or phone. We also strongly recommend that you consult with your healthcare provider about the trials that may interest you and refer to our terms of service below.

Intermountain Medical Center, Murray, Utah




Intermountain Medical Center

Murray, Utah, 84107

Site Contact

Valerie Aston


For more information, please contact PHA at and refer to the terms of service below.

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